Prefilled, single dose, one time use, self-destructing, auto-disabling safety syringe with an injection molded barrel; method of manufacture and method of use

ABSTRACT

The present invention relates to a single dose, one time use, self-destruction, auto-disabling safety syringe with an injection molded barrel. The invention successfully addresses and solves the problems of the prior art by combining the use of COC injection molding with the advantages presented by the ampoule cartridge and the traditional safety syringe all integrated into a single device. A pre-filled ampoule or barrel is molded with minimal draft enabling the syringe&#39;s piston plunger to be partially self-lubricated by the syringe&#39;s contents. The addition of an internal auto disabling coupler to the piston plunger allows the device to be used only a single time. In addition, the present invention&#39;s structure is such that its safety sleeve necessarily moves forward to cover the syringe&#39;s needle after use. The present invention&#39;s elements, as combined, solve the biocompatibility and safety problems of the prior art and provide an exact dose, prefilled, single time use, cartridge safety syringe.

CROSS-REFERENCE TO RELATED APPLICATION

I hereby claim the benefit under Title 35, United States Code Section119(e) of any United States Provisional Application(s) listed below:

-   Application No.: 60/800,813

Filing Date: May 16, 2006

BACKGROUND OF THE INVENTION

1. Technical Field of the Invention

The present invention relates generally to safety hypodermic syringesand, more particularly, but not by way of limitation, to a prefilled,single dose, one time use, self-destructing, auto disabling hypodermicsyringe with an injection molded barrel.

2. Description of the Background Art

The alarming increase of human-fluid borne infectious diseases, theirvarious avenues of spread, and especially, the increase risk of spreaddue to multiple uses or accidental needle sticks of hypodermic injectionsystems cannot be ignored.

Over the last twenty years, there have been numerous developments in thefield of single dose, prefilled, disposable syringes. U.S. Pat. No.4,596,561 to Meyer et al., describes and claims a non-reusable syringecomprising a tamper-proof packaging which insures that the propermedication is contained in the barrel, free of any contaminant.

U.S. Pat. No. 5,575,776 to Bleiweiss, discloses and claims a singledose, prefilled, disposable syringe arrangement. The '776 patent'ssystem comprises an outer casing surrounding the syringe in the packagedstate, which is collapsible to act as a plunger during use of thesyringe. Bleiweiss' patent stresses the single use capability of thesyringe, followed by secured disposal and non-reuse.

Pre-filled syringes were originally made from glass or borosilicate. Asit is well known in the art, glass structures allow variations in the pHof the contents thus resulting in at least some degradation. Anotherdisadvantage of borosilicate syringes is the need for a medical gradesilicone stopper lubricant to advance the plunger. In many cases,silicone tends to break down the contents' proteins thus decreasing theeffectiveness of the drug being administered. In addition, injuries fromglass syringes and needle-sticks have allowed the spread of blood bornepathogen diseases such as acute or chronic hepatitis, HIV, or AIDS.

In more recent times, some of the problems outlined above haveescalated. Caregivers in the hospital, hospice and home-healthcareenvironments are further exposed to human fluid borne, potentiallyinfectious, diseases while conducting procedures in patients who, due totheir condition, may not hold still during an injection. Anotherpotentially dangerous situation takes place if the caregiver drops thesyringe accidentally receiving a needle stick or is stuck while cleaninga tray. There have been reported cases where a custodian has received apotentially infectious injury while cleaning the pieces of broken glassfrom a syringe. Caregiver and worker injuries can significantly increasethe costs of medical care as well as insurance for the healthcarefacility. All of those costs are usually passed on to the patients.

Healthcare providers are supposed to deposit used syringes in a sharpscontainer immediately after use. Many caregivers place syringes on atray or cart and injuries can and do occur for failure to follow theproper disposal protocol. Medical device companies have tried tomanufacture add on needle stick avoidance devices and spring-loadedcovers or shields for the glass syringe. Many of the commerciallyavailable devices have unacceptably high failure rates and, in someinstances, cannot be securely engaged to the syringe. Most efforts inthe stick-avoidance area have taken place in the context ofmanufacturers trying to assist healthcare providers in compliance withthe newly enacted FED/OSHA mandate 29 CFR Part 1910 and EuropeanParliament resolutions; Occupational Exposure to Blood borne Pathogens;Needle sticks and other Sharps Injuries.

Because of the many shortcomings of glass syringes, the next generationof prefilled syringes of the prior art was manufactured usingpolypropylene. Some polypropylene prefilled syringes of the prior arteven had spring-loaded retractable needles, hinged needle guards andflip-over covers. The type of highly clarified polypropylene resin usedpresented problems in that it posed a risk of leechables andextractables in the resin altering the contents of the medication. Inaddition, the stopper required a medical grade silicone lubricant toadvance the plunger. It is well known in the art that silicone can breakdown the proteins in the medication, rendering it less effective to thepatient. The FDA has denied new drug application approvals ofmedications being administered via prefilled syringes based onlaboratory testing and two-year shelf life restrictions. Accordingly,the safety syringes in the market today are primarily used as general ormulti purpose syringes.

Most recently, cyclic olefin copolymer (“COC”) has been introduced asthe new FDA approved state-of-the-art replacement for glass. COC hasexcellent barrier properties and is virtually shatterproof. COC also hasthe look of glass and does not contain crystalline, which makes it asclear as glass. COC is also bio-compatible, so that it does not alterpre-filled medications in the ways polypropylene syringes can. Thosecharacteristics make COC an ideal material to aid overcoming some of theshortcomings of the safety syringe prior art mentioned above.

In the case of COC syringes, many medical manufacturers “blow-mold” theresin into the shape of a syringe component. COC syringes, which lackmost, if not all, of the required safety features, present most of thesame shortcomings evidenced in the existing art, including needle-sticksand accidental, unintentional or intentional re-use. Furthermore, theCOC syringe's stopper still requires a medical grade silicone lubricantto advance the plunger. Again, the silicone can break down proteins inthe syringe's content, potentially diminishing the effectiveness of themedication being administered.

COC medical ampoules or blow molded vials are FDA approved and havegained a large percentage of market share. They cannot be blow moldedand manufactured as a cartridge because both ends are initially open.During the manufacturing process, the back end is sealed with a pistonplunger and the front end is sealed with thermoplastic elastomer(“TPE”), or a rubber seal and an aluminum cap.

Despite prior attempts to comply with FED/OSHA and European Parliamentmandates, no compliant, mechanically suitable engineered safety syringeexists for use by the professional caregiver or patient for the safestpossible biocompatible safety syringe with anti-needle-stick andauto-disable features. The present invention fulfills all of thoserequirements and provides an alternative arrangement which effectivelyaddresses and cures all of the shortcomings of the prior art. Thepresent invention is the first pre-filled integrated engineered safetysyringe.

In addition, none of the prior art discloses a syringe for doses under3.0 mL. A small bio-compatible safety syringe is critically needed toaddress two problems. The first problem is the shortage of refrigeratedor temperature-controlled space in most medical settings. A smallsyringe with a short plunger can help to resolve space issues for lowvolume vaccines, biologics and allergens. Pediatrics is the second areawhere a small syringe is needed. A small syringe can accommodate asmaller needle hub and needle. The present invention can be scaled downin length for doses as small as 0.5 mL. A small-sized hub for thesmaller syringe is also disclosed.

SUMMARY OF THE INVENTION

The present invention addresses and solves the problems of the prior artby combining the use of COC injection molding with the advantagespresented by the ampoule cartridge and the traditional safety syringeall integrated into a single compliant device. Molding the pre-filledampoule cartridge with minimal draft enables the plunger to be partiallyself-lubricated by the syringe's contents and minimizes the use ofsilicone. The addition of an internal auto disabling coupler to thepiston plunger allows the device to be used only a single time. Inaddition, the present invention comprises opposing tabs at the proximalend, a universal hub attached to the distal end, and an integratedsafety sleeve with forward mounted opposing tabs. That arrangementallows the sleeve to move only in a forward direction and lock in allforward positions to cover the needle. Once the sleeve is locked in theforward position, where it encapsulates the needle, it is no longerpossible to retract it and expose the needle. Any attempt to forciblyexpose the needle once encapsulated, results in the sleeve and theneedle hub disengaging from the cartridge barrel as a single unit. Thesyringe of the present invention is truly a hybrid in that the syringecan be pre-filled or general purpose; it can accommodate universal hubsor luer hubs; and it can be manufactured in small sizes for low dose andpediatric use. The inventive elements of the present invention, ascombined, solve the biocompatibility, size and safety problems of theprior art and provide an exact dose, prefilled, single time use,cartridge safety syringe.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE INVENTION

Structurally, the single use, self-destructing, safety syringe of thepresent invention comprises an injection molded COC ampoule cartridgesyringe barrel (1) suitable for receiving an injectable liquid. Thebarrel comprises opposite proximal and distal ends, an outer surface andan inner surface. The proximal end is open and is capable of receiving aplunger (12). The barrel is molded so that the proximal end extends intotwo opposing tabs (3) perpendicular to the barrel. Each tab comprises anergonomic radius section (45) following extension point of the tab fromthe barrel, continuing into a single standing rib (4) for comfortable,non-slip use. A recessed well (10) is located on the outer surfacebetween the two opposing tabs, the well comprising a droplet of ink or alabel with ink, capable of acting as a sterilization indicator. Theindicator can be selective (such as gamma) or multi-process (such asE-beam). The indicator can be colorless and change to a color or can bea color that changes to another color when sterilization is compromised.The opening (2) in the proximal end is capable of engaging anauto-disabling coupling subassembly which is further connected to thestopper (29). The inner surface of the distal end of the barrelcomprises three forward positioned internal flat ribs (8) so that aninterference (9) with the coupling sub-assembly is created allowing therelease of the coupling sub-assembly upon moving the plunger forward andcompleting the administration of the syringe's contents. The distal endfurther comprises an opening (6) and a universal receiving neck (5). Theneck comprises an interior and an exterior, the interior comprising aninternal retention rib (7) for connection of the male needle hub (39) tothe ampoule cartridge syringe barrel (1). The outer surface of thebarrel is capable of receiving a printed DNA ink identification toidentify its content as an anti-counterfeit drug measure. Alternately, aDNA ink tear-off label can be affixed to the barrel. The tear-off labelcan be attached to a patient's charts after drug administration to helptrack administration of drugs.

The stopper (29) is made from non-reactive compression moldedthermoplastic elastomer, and comprises a piston-shaped exterior and aflat distal end. The stopper's configuration significantly reduces thedead space volume in the ampoule cartridge barrel. The proximal endcomprises a threaded female receiving opening for screw-insertion of thecoupler's forward male threaded end (24). The pre-filled medication (11)is contained in the barrel between the stopper and the barrel's neck.

The coupler (22) is made from polypropylene. It comprises a forward malethreaded end (24), an increased diameter circular standing flat rib (25)and a rear female end. The threaded male forward end (24) comprises acentered protrusion and is capable of being screw-inserted into thestopper's threaded female receiving end (29) and being locked firmlyinto place by turning the male forward end 360 degrees clockwise. Theincreased diameter standing flat rib (25) is capable of passing thebarrel's internal flat ribs, seating the stopper and allowing thestopper to advance to a fully extended distal position in the barrel.The rear female end of the coupler diameter is reduced and comprises andinternally threaded receiving means (27) and four longitudinally splitside arms (26), the side arms comprising multiple standing flex fingerscapable of engaging the coupler ring (19) through snap-assembly. Thecoupler is capable of aspirating proximally and distally inside thebarrel as part of an interconnected assembly. The coupler is furthercapable of interacting with the barrel's internal flat ribs (8) to allowthe release of the coupler upon completion of the administration of thesyringe's contents.

The cylindrical coupler ring is designed to have a large diameter wallthickness (21) that does not allow the ring to flex. The coupler ring iscapable of being snap-assembled over the coupler's side arms to createan inside dimension interference (20) which maintains the coupler andring assembly in place.

The plunger (12) is made from polypropylene or COC and comprises acylindrical shaft, the shaft being smaller in diameter than the barrel,the shaft comprising opposite proximal and distal ends. The distal endis circular so it can be received by and be inserted into the barrel'sproximal end opening. The proximal end ends in a cylindrical disk (14),the disk comprises a circular raised rib (15) along the exterior of thedisk's diameter and an embossed logo to frictionally reduce slippage.The shaft of the plunger is X-braced (13) to a forward positionedstanding raised rib (16) that approximates the inner diameter of thebarrel and self centers the plunger along the inside diameter of thecartridge barrel. The plunger's distal end comprises a reduced diametersection near the distal end to allow space for the coupler ring (19) todisengage from the plunger. The plunger's distal end further comprises aself-centering threaded male end (18) being capable of being insertedthrough the coupler ring and firmly snap-fitting into the coupler'sthreaded receiving means. The plunger is capable of releasing thecoupler upon moving the plunger forward, after administration of thesyringe's contents. In an alternative embodiment of the invention,wherein the syringe is not prefilled, the plunger's shaft is longer toallow a dose to be drawn from a separate container.

The self-disabling coupling sub-assembly interconnects the stopper (29),the coupler (22), the coupler ring (19), and the plunger (12), which issnap-assembled into a single unit. The sub-assembly is inserted into theproximal end of the cartridge barrel (1) after the barrel is pre-filledwith medication. The internal coupling sub-assembly aspirates proximallyand distally inside the cartridge barrel as one interconnected assembly.When the stopper, coupler and coupler ring are advanced by the plungerto a distal position, the coupler ring interference (20) engages thethree flat ribs (8) of the cartridge barrel releasing the coupler ring(19) from the coupler (22), allowing the flex fingers to expand, whichin turn creates an interference from the stopper (29) against the flatribs of the cartridge and allows the coupler's flex fingers (26) todisengage from the plunger, rendering it useless for re-injection. Thecoupler subassembly is capable of pushing the single dose of medicationlocated in the barrel between the barrel's neck and the stopper out ofthe barrel through the barrel's neck when the plunger is advanced to adistal position in the barrel.

A plunger cap (57) such as that used in an all-purpose syringe can beused with the syringe of this invention to create a dynamic interfacetriple seal lock (58) and a complete sterile internal environment.

A male staked needle hub (39) is made from polypropylene and is engagedto the barrel's universal receiving neck (5) by a male snap insertionand is held in place by the undercut of the male hub and the standinginternal retention rib (7) of the barrel's neck. The hub comprises auniform internal surface (42) that aligns with the exterior of thecartridge neck creating a uniform surface interference for snapassembly. The hub further comprises opposing dual flex fingers (44) thatlock into the sleeve's opposing locks (35) for anti-needle stickprotection. The hub also comprises dual opposing flat ribs (43) thatallow the sleeve to move distally and dual opposing flex fingers (44)that lock the sleeve in all forward positions, protecting the caregiverfrom the needle as the sleeve extends distally past the needle into afully extended distal position. The hub also comprises an extendedforward end with three raised ribs (40) that create a sterile barrierwhen connected to the needle cap/sheath (47). The hub further comprisesa dimple (41) at the forward end with UV-cured adhesive and spiralrelief dimensional undercuts and a center opening (53) with low deadspace that create a mechanical lock (59) when a hollow needle (46) orcannula lumen is inserted and adhered to through the center opening ofthe hub.

An elliptical shaped sleeve (30) made from COC cyclic olefin copolymeris capable of sliding over the cartridge barrel (1) and snap assemblingto the needle hub (39). The length of the sleeve varies depending on thelength of the needle that will be used with the syringe, so that thesleeve is capable of completely encapsulating the needle. The sleevecomprises an inner side, an outer side, an open proximal end, an opendistal end, and two opposing series of horizontal locking slats (35).The two opposing series of horizontal locking slats extend from theproximal end to the distal end and have rectangular holes that extendfrom the inner side to the outer side between the slats. The slats arecapable of engaging the hub's flex fingers (44), this engagementresulting in the slats being oriented ninety degrees away from theneedle hub's dual opposing flat ribs (43) and the sleeve and the hubbeing locked together. The hub's flex fingers (44) are capable oflocking onto any of the slats in forward distal positions as the sleeveis advanced. The flex fingers prevent the sleeve from moving proximally,so that only distal advancement is possible (37). Distal advancement ofthe sleeve results in anti-needle stick protection as the sleeve islonger than the needle and is capable of extending past the needle,encapsulating it, as is shown in FIG. 12. The inner side of the proximalend comprises interference shelves (33) capable of irreversibly engagingthe needle hub when the sleeve is extended past the locking slats to afully distal position. When the sleeve is advanced to its forward-mostdistal position, the interference shelves (33) at the proximal end ofthe sleeve firmly lock onto the needle hub in such a way that the sleevecan not be advanced further. Any attempt to further advance the sleevewill result in the hub disengaging from the barrel's receiving neck, aspictured in FIG. 13, resulting in complete needle stick protection forany person subsequently handling the syringe or its parts. The outerside comprises a bioindicator (36) and a raised rib (34) extending alongthe center of each set of locking slats, the raised ribs beingperpendicular to the slats. The bioindicator provides additionalidentification regarding the syringe or its contents. In alternativeembodiments, the bioindicator can be located on the barrel. The distalend of the sleeve is molded so that the distal end extends into twoopposing tabs (31) perpendicular to the sleeve, each tab comprising anergonomic radius section following the extension point of the tab fromthe sleeve, continuing into a single standing rib (32) for comfortablenon-slip use. The tabs being capable of being rotated axially (38) whenthe sleeve is engaged with the hub flex fingers (44), allowing for thecorrect needle bevel orientation for injection. Upon a completedadministration of the syringe's contents, the user holds the sleeve'stabs (31) and withdraws the barrel tabs (3), encapsulating the needlewithout ever exposing the needle. The sleeve's elliptical shape iscapable of creating a lens effect, resulting in 100 percent visibilityof the contents in the barrel being administered.

The needle cap (47) comprises an exterior shell, an interior, anengaging end and a closed end. The exterior shell is made of high-impactpolypropylene that is impervious to the tip of the needle. The cap'sinterior comprises a soft thermoplastic elastomer (50) capable ofengaging the needle. Surrounding the needle with TPE prevents leakage ofthe pre-filled barrel's contents through the needle. The engaging end iscapable of firmly engaging the three standing coaxial ribs (40) on theneedle hub's extended forward end in such a way that a sterileenvironment is created in the space between the needle and the cap, andkeeping the cap in place. The cap further comprises four standingcoaxial ribs (49) extending horizontally around the outer circumferenceof the closed end, being capable of creating a non-slip grip for ease ofremoval of the cap from the hub.

In an alternative embodiment of the invention, illustrated by FIGS. 21and 22, the universal hub is interchangeable from a staked hub to a luerhub (51) during assembly, allowing for the choice of needle/lumen forthe proper procedure. The luer hub comprises flex fingers (54) capableof engaging the sleeve in all forward positions. The luer hub furthercomprises a two-part cap (55) made of polypropylene and TPE thermoplastic elastomer with a threaded base (56). The threaded basecorresponds to threads on the luer hub (52). The screw tightening of thetwo-part cap compresses the TPE seal creating a sterile barrier.

In an alternative embodiment of the invention, the length of the syringeis scaled-down to accommodate a small dose between 0.5 and 3.0 mL and asmall universal needle hub is used instead of the hub of the preferredembodiment. The small universal hub is illustrated by FIGS. 18 and 19.The small hub comprises smaller flex fingers (45) and dual opposinglinear ribs (43) for accommodating a smaller sleeve. This smallerembodiment addresses the need for small-sized safety syringes forlimited space, low doses and pediatric applications.

In an alternative embodiment of the invention for general purpose use,the syringe is not pre-filled with medication. The dose is drawn intothe syringe through the needle from a separate medicine vial. Theplunger is longer to allow for medication to be withdrawn from amedicine vial. The syringe coupler sub-assembly parts are different, aspictured in FIG. 7, to allow for quick assembly for high volumeautomated manufacture. The plunger (12) comprises a male chamferedforward distal end (18) for snap insertion into the female chamfered end(27) of the coupler. The coupler comprises a female chamfered end (27)and a male chamfered forward end (23). The stopper (28) comprises afemale chamfered end that engages the male chamfered forward end of thecoupler. The standard needle cap/sheath is used for the general purposeembodiment, as is pictured in FIG. 17. The standard needle cap comprisesfour standing tapered ribs (48) extending vertically, allowing fornon-slip removal of the cap from the syringe. This general purposeembodiment can incorporate other alternative embodiments, such as theluer hub or low dose size, resulting in a hybrid syringe with maximumfunctional flexibility.

The method of using the pre-filled safety syringe of this inventioncomprises the steps of: (1) removing the syringe from a sterile blisterpackage; (2) removing the needle cap; (3) aligning the needle for properuse by rotating the sleeve; (4) administering the syringe's contents tothe patient via injection by depressing the plunger to a full distalposition for completed injection; (5) holding the forward sleeve tabs;(6) pulling back the rear cartridge barrel tabs which results inencapsulating the hub and needle into the sleeve; (7) allowing theinternal coupler to disengage automatically which results the plungerbeing released form the internal coupler, resulting in a syringe whichcannot be re-used accidentally or intentionally under any conceivableset for circumstances; and (8) placing the spent device in a sharpscontainer.

The structural features of the syringe of this invention can only beachieved due to the horizontal molding COC manufacturing process. Theinternal components are male to female interconnected or screw fit andare inserted into the proximal end of the cartridge barrel. The sleeveis slid over the cartridge and the hub, needle, and sheath aresnap-assembled to a universal neck at the distal end of the cartridgebarrel. The automatic snap assembly feature of the present invention canonly be achieved via the design relationship of same axis centerlinepart design. The centerline snap assembled components are designed forhigh-speed sterile assembly. The coupler, coupler ring, hub and otherpolypropylene parts can be tinted for color-coding to indicate the typeof medication, patient or other use for that syringe.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a frontal view of the fully assembled preferred embodiment ofthe invention.

FIG. 2 is a frontal view of the empty barrel.

FIG. 3 is a frontal view of the barrel and the alternative embodiment ofthe coupling sub-assembly.

FIG. 4 is a frontal view of the pre-filled barrel and the alternativeembodiment of the coupling sub-assembly.

FIG. 5 is a frontal view of the barrel and the alternative embodiment ofthe auto-disabled coupling sub-assembly in the fully distal position.

FIG. 6 is a frontal view of the cartridge barrel with the alternativeembodiment of the auto-disabled coupling sub-assembly when the plungeris retracted in an attempt to reuse the syringe.

FIG. 7 is an isometric exploded view of the alternative embodiment ofthe coupling sub-assembly.

FIG. 8 is an isometric exploded view of the preferred embodiment of thecoupler sub-assembly.

FIG. 9 is a frontal view of the alternative embodiment couplingsub-assembly interference with the barrel.

FIG. 10 is a frontal view of the sleeve and hub attached to the barrel.

FIG. 11 is a frontal view of the sleeve snap-assembled to the hub in thefirst locking position.

FIG. 12 is a frontal view of the sleeve fully extended to the distalposition, encapsulating the hub and needle.

FIG. 13 is a frontal view of the sleeve removed from cartridge barrel,encapsulating the hub and needle.

FIG. 14 is an isometric exploded view of the preferred embodiment of theinvention.

FIG. 15 is an isometric view of the preferred embodiment of theinvention.

FIG. 16 is a frontal view of the needle cap on the syringe in thepreferred embodiment of the invention.

FIG. 17 is a frontal view of a standard needle cap on the syringe in thegeneral purpose alternative embodiment of the invention.

FIG. 18 is an isometric view of the small universal hub of analternative embodiment of the invention with a staked needle.

FIG. 19 is an isometric cross-sectional view of the small universal hubof an alternative embodiment of the invention with a staked needle.

FIG. 20 is an isometric view of the universal hub of the preferredembodiment of the invention with a staked needle.

FIG. 21 is an isometric cross-sectional view of the universal hub of thepreferred embodiment of the invention with a staked needle.

FIG. 22 is an isometric view of the luer hub of an alternativeembodiment of the invention.

FIG. 23 is an isometric cross-sectional view of the luer hub and cap ofan alternative embodiment of the invention.

FIG. 24 is a top view of syringe cartridge barrel.

FIG. 25 is a perspective view of the plunger with the raised rib andembossed logo.

1. A prefilled, single dose, one time use, self-destructing,auto-disabling safety syringe comprising: a. an injection molded, cyclicolefin copolymer, ampoule cartridge syringe barrel, the barrelcomprising opposite proximal and distal ends, the proximal end beingopen so that it is capable of receiving a plunger, the barrel beingmolded so the proximal end extends into two opposing tabs perpendicularto the barrel, each tab comprising an ergonomic radius section followingthe extension point of the tab from the barrel, continuing into a singlestanding rib for comfortable non-slip use, the barrel comprising anouter surface and an inner surface, the outer surface being capable ofreceiving ink printing to identify its content, the proximal end's outersurface comprising a recessed well, the well comprising a sterilizationindicator, the barrel's distal end comprising three forward positionedinternal flat ribs and a universal receiving neck, the neck comprisingan interior surface and an exterior surface, the interior surfacecomprising an internal retention rib, the barrel being suitable toreceive an injectable liquid; b. a stopper made from non-reactivecompression molded thermoplastic elastomer, the stopper comprising apiston-shaped exterior, a proximal end and a flat distal end configuredso it significantly reduces the dead space volume in the barrel, thestopper's proximal end further comprising a threaded female receivingopening; c. a polypropylene coupler comprising a forward male threadedend, an increased diameter circular standing flat rib and a rear femaleend, the forward end comprising a centered protrusion and being capableof engaging the stopper's female receiving opening by inserting theforward end into the receiving opening and turning the coupler threehundred and sixty degrees clockwise, the flat rib being capable ofseating the stopper and allowing the stopper to advance to a fullyextended distal position in the barrel, the rear female end of thecoupler's diameter being reduced and comprising an internally threadedreceiving means and four longitudinally split side arms, the side armscomprising multiple standing flex fingers capable of engaging a couplerring, the coupler being further capable of aspirating proximally anddistally inside the barrel as one interconnected assembly, the couplerbeing capable of interacting with the barrel's internal flat ribs toallow the release of the coupler upon completion of the administrationof the syringe's contents; d. a rigid, cylindrical coupler ring, thering being capable of being firmly snap-fitted onto the coupler's sidearms to create an inside dimension interference which allows a firmengagement of the coupler and the coupler ring, the coupler ring beingcapable of being disengaged from the coupler; e. a plunger comprising acylindrical shaft, the shaft being smaller in diameter than the barrel,the shaft comprising opposite proximal and distal ends, the distal endbeing circular so it can be received by and be inserted into thebarrel's proximal end opening, the proximal end ending in a cylindricaldisk, the cylindrical disk comprising a circular raised rib along theexterior of the disk's diameter and a embossed logo capable offrictionally reducing slippage, the shaft being X-braced to aforward-positioned, standing raised rib that approximates the innerdiameter of the barrel and centers the plunger along the inside diameterof the cartridge barrel upon insertion, the shaft's distal end furthercomprising a self-centering snap-assembled threaded male end comprisinga snap attachment means, the threaded male end being capable of beinginserted through the coupler ring and firmly snap-fitting into thecoupler's threaded receiving means, the plunger being capable ofreleasing the coupler upon moving the plunger forward, afteradministration of the syringe's contents; f. the stopper, the coupler,the coupler ring, and the plunger forming an auto-disabling couplingsub-assembly, the sub-assembly being capable of pushing the single doseof medication located in the barrel between the barrel's neck and thestopper; g. the sub-assembly being capable of snap assembly into asingle unit and being inserted into the proximal end of the cartridgebarrel so that when the stopper, coupler, and coupler ring are advancedby the plunger to a distal position the coupler ring interferenceengages the three flat ribs of the barrel releasing the coupler ringfrom the coupler and allowing the flex fingers to expand, which in turncreates an interference from the stopper against the flat ribs of thebarrel and allows the coupler's flex fingers to disengage from theplunger rendering the syringe useless; h. a plunger cap being capable ofcreating a sterile internal environment due to a dynamic interfacetriple seal lock; i. a polypropylene male needle hub comprising a rearend and a forward end, the hub being capable of being connected to thebarrel by a male snap insertion to the barrel's universal receiving neckand held in place by an undercut of the male hub and the standinginternal retention rib of the barrel's neck, the hub's rear endcomprising a uniform internal surface capable of being aligned with theexterior of the barrel's neck creating a uniform surface interferencefor snap assembly, the hub further comprising opposing dual flex fingersand dual opposing flat ribs, the dual flex fingers being capable ofengaging a sleeve, the hub's forward end comprising three raised ribsand a dimple, the raised ribs being capable of creating a sterilebarrier, the dimple comprising uv-cured adhesive capable of adhering aneedle, multiple spiral relief dimensional undercuts and a low deadspace center opening; j. a needle or cannula capable of being insertedinto and adhered to central opening of the needle hub and creating amechanical lock with the dimple's spiral relief dimensional undercutsand uv-cured adhesive; k. a needle cap comprising an exterior shell, aninterior, an engaging end and a closed end, the exterior shell beingmade of high-impact polypropylene, the interior comprising softthermoplastic elastomer capable of engaging the needle in such a waythat leakage of the barrel's contents is prevented, the engaging endbeing designed to firmly engage the three standing coaxial ribs on theneedle hub's surface preserving the sterile environment, the cap furthercomprising four standing coaxial ribs extending horizontally around theouter circumference of the closed end being capable of creating anon-slip grip for ease of removal of the cap from the hub, the cap beingcapable of connecting to the hub's extended forward end's raised ribs insuch a way that a sterile environment is created in the space betweenthe needle and the cap; and l. a transparent cyclic olefin copolymerelliptical shaped sleeve, the sleeve being capable of sliding over thebarrel for snap assembly to the needle hub's flex fingers, the sleeve'slength being determined by the length of the needle, the sleevecomprising an inner side, an outer side, an open proximal end, an opendistal end, and two opposing series of horizontal locking slats, the twoopposing series of horizontal locking slats extending from the proximalend to the distal end of the sheath and comprising rectangular holesthat extend from the inner side to the outer side between the slats, theslats being capable of engaging the hub's flex fingers, resulting in theslats being oriented ninety degrees away from the needle hub's dualopposing flat ribs and the sleeve and the hub being locked together, thehub's flex fingers being capable of locking onto any of the slats inforward distal positions as the sleeve is advanced and preventing thesleeve from moving proximally, the inner side of the proximal endcomprising interference shelves capable of irreversibly engaging theneedle hub when the sleeve is extended past the locking slats to a fullydistal position, the fully distal position resulting in anti-needlestick protection as the sleeve is capable of extending past the needle,the outer side comprising a bioindicator and a raised rib extendingalong the center of each set of locking slats, the raised ribs beingperpendicular to the slats, the distal end being molded so the distalend extends into two opposing tabs perpendicular to the sleeve, each tabcomprising an ergonomic radius section following the extension point ofthe tab from the sleeve, continuing into a single standing rib forcomfortable non-slip use, the tabs being capable of being rotatedaxially when the sleeve is engaged with the hub flex fingers allowingfor the correct needle bevel orientation for injection, the sleeve'selliptical shape being capable of creating a lens effect, resulting inone hundred percent visibility of the contents of the barrel.
 2. Theprefilled, single dose, one time use, auto-disabling, self-destructing,safety syringe according to claim 1, wherein the plunger is manufacturedfrom a material selected from the group consisting of polypropylene orcyclic olefin copolymer.
 3. The prefilled, single dose, one time use,auto-disabling, self-destructing, safety syringe according to claim 1,wherein the hub is a staked hub and the needle is a traditional syringeneedle.
 4. The prefilled, single dose, one time use, auto-disabling,self-destructing, safety syringe according to claim 1, wherein the hubis a luer hub to which a needle or lumen can be attached, said luer hubcomprising a two-part cap and a threaded base, the two-part cap beingmade of polypropylene and thermo plastic elastomer, and the two-part capbeing capable of compressing the thermo plastic elastomer creating asterile barrier upon screw tightening of the cap onto the hub.
 5. Theprefilled, single dose, one time use, auto-disabling, self-destructing,safety syringe according to claim 1, wherein the barrel, the plunger andthe sleeve are shorter in length for small doses of injectable liquid,the hub is a small universal needle hub, and the small needle hubcomprises small flex fingers and small dual opposing linear ribs.
 6. Thesingle dose, one time use, auto-disabling, self-destructing, safetysyringe according to claim 1, wherein: a. the plunger comprises achamfered male distal end capable of snap-insertion into a coupler'schamfered female receiving means; b. the coupler comprises a chamferedmale distal end and a chamfered female receiving means at the proximalend, the male distal end being capable of firmly snap-fitting into astopper's chamfered female receiving end, and the female receiving meansbeing capable of firmly snap-fitting with the plunger's distal end; c.the plunger being elongated; and d. the stopper comprising a chamferedfemale receiving opening capable of firmly snap-fitting with the maledistal end of the coupler so that the single dose can be drawn from aseparate container prior to injection.
 7. A method of using theprefilled, single dose, one time use, auto-disabling, self-destructing,safety syringe, comprising the steps of: a. providing a syringe as thatclaimed in claim 1 contained in a sterile blister package; b. removingthe syringe from the sterile blister package; c. removing the needlecap; d. properly orienting the needle by twisting the sleeve tabs; e.administering the syringe's contents to a patient via injection bydepressing the plunger to a full distal position or completed injection;f. holding the sleeve tabs; g. pulling back the barrel tabs resulting inencapsulating the hub and needle into the sleeve without the needle everbeing exposed; h. allowing the coupling sub-assembly to disengageautomatically resulting in the plunger being released from the internalcoupler, further resulting in the syringe not being capable of beingreused accidentally or intentionally under any conceivable set ofcircumstances; and i. placing the used syringe in a sharps container.